WA22366A and WA22367A SurgMaster Working Elements Instructions Jan 2011

1 CONTENTS 1 General Information... 4 1.1 Intended Use... 4 1.2 Instruction Manuals... 8 1.3 Upon Delivery... 9 1.4 Manufacturer/Distributor... 11 2 Terminology... 12 2.1 Shape of HF-Resection Electrodes... 15 2.2 Color Codes of HF-Resection Electrodes... 18 3 Compatible Components... 19 3.1 Before Use... 23 3.2 Inspection and Testing... 24 4 Use... 26 4.1 Preparation... 27 4.2 Procedure... 31 4.3 After Use... 36 5 Reprocessing of WA22366A, WA22367A, WA22351A, WA22355A, WA22538A... 37 5.1 Cleaning... 39 5.2 Maintenance... 42 6 Repair... 43

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1 General Information 1.1 Intended Use WA22366A, WA22367A Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode. Do not use it for any other purpose. WA22301D, WA22302D, WA22305D, WA22306D, WA22331D, WA22332D, WA22351A, WA22351C, WA22355A, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538A, WA22538C, WA22539D, WA22558C HF-resection electrode for transurethral endoscopic diagnosis and treatment in urological surgical procedures for use in the prostate, bladder and bladder neck involving the resection, ablation or removal of soft tissue and where hemostatis is required. Do not use it for any other purpose. WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C HF-resection electrode for transurethral endoscopic diagnosis and treatment in urological surgical procedures for use in the prostate, bladder and bladder neck involving the resection, ablation or removal of soft tissue and where hemostatis is required. Do not use it for any other purpose.

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5 WA22557C HF-resection electrode for plasma vaporization for transurethral endoscopic diagnosis and treatment in urological surgical procedures for use in the prostate, bladder and bladder neck involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. Do not use it for any other purpose. WA22657C HF-resection electrode for plasma vaporization for transurethral endoscopic diagnosis and treatment in urological surgical procedures for use in the prostate, bladder and bladder neck involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. Do not use it for any other purpose.

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6 Applications HF-resection electrodes are classified according to their compatibility with coagulation, cutting, or vaporization. Refer to the table for compatible applications of the selected HF-resection electrode. These devices are intended to be used in an irrigated environment. Use HFresection electrodes only for compatible applications. + = compatible – = not compatible Article number

Coagulation

Cutting

Vaporization

WA22301D

+

+

–

WA22302D

+

+

–

WA22305D

+

+

–

WA22306D

+

+

–

WA22331D

+

+

–

WA22332D

+

+

–

WA22351A/C

+

–

–

WA22355A/C

+

+

–

WA22503D

+

+

–

WA22507D

+

+

–

WA22521C

+

+

–

WA22523C

+

+

–

WA22557C

+

–

+

WA22558C

+

+

–

WA22537D

+

+

–

WA22538A/C

+

–

–

WA22539D

+

+

–

WA22602D

+

+

–

WA22603D

+

+

–

WA22606D

+

+

–

WA22607D

+

+

–

WA22621C

+

+

–

WA22623C

+

+

–

WA22632D

+

+

–

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7 Article number

Coagulation

Cutting

Vaporization

WA22651C

+

–

–

WA22655C

+

+

–

WA22657C

+

–

+

Specific urological indications HF-resection electrodes compatible with coagulation/ cutting: -- Transurethral resection in saline (TURis) -- Transurethral prostatectomy, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia -- Transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy HF-resection electrodes compatible with vaporization: -- Treatment of benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms -- Transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis) Medical use This product is to be used only in a medical facility by trained medical personnel.

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8 CAUTION! For single use only The following products are for single use only. Do not reuse or attempt to resterilize. WA22301D, WA22302D, WA22305D, WA22306D, WA22331D, WA22332D, WA22351C, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538C, WA22539D, WA22557C, WA22558C, WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C, WA22657C Medical Device Directive (Europe) This product complies with the requirements of Directive 93/42/EEC concerning medical devices.

1.2 Instruction Manuals NOTE! Instruction manual set The complete instruction manual set for this product consists of this product-specific instruction manual (delivered together with this product) and the systemrelated instruction manual, entitled “Olympus Endoscopy System Guide” (supplied with Olympus telescopes). Immediately contact an Olympus representative if either manual is missing or lost. Keep the instruction manual set in a safe, accessible location.

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9 WARNING! Read all instruction manuals thoroughly Before use, read this manual, the Olympus Endoscopy System Guide, and the manuals for all other equipment which will be used during the procedure. An insufficient understanding of the dangers, warnings, cautions, and information in these manuals can result in death, serious injury, or equipment damage.

1.3 Upon Delivery Inspect immediately • Make sure that the shipping case contains all of the items listed below. • Contact your Olympus representative or an authorized service center if any items are missing or damaged. Contents working element Working elements: WA22366A, WA22367A -- Instruction manual -- Working element

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10 Contents HF-resection electrode HF-resection electrodes: WA22301D, WA22302D, WA22305D, WA22306D, WA22331D, WA22332D, WA22351A, WA22351C, WA22355A, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538A, WA22538C, WA22539D, WA22557C, WA22558C -- Access information sheet -- HF-resection electrode

Contents HF-resection electrode HF-resection electrodes: WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C, WA22657C -- Access information sheet -- HF cable -- HF-resection electrode

Unpacking • Remove the product from the packaging. Do not use the packaging for routine storage.

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11 CAUTION! Sterilized product* Store the following products in a dry and clean environment at room temperature. Avoid direct contact with sunlight, high temperature, and high humidity. *Applies to the following products: WA22301D, WA22302D, WA22305D, WA22306D, WA22331D, WA22332D, WA22351C, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538C, WA22539D, WA22557C, WA22558C, WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C, WA22657C

1.4 Manufacturer/Distributor Manufacturer: Olympus Winter & Ibe GmbH Kuehnstraße 61 22045 Hamburg Germany Distributor: Olympus Winter & Ibe GmbH Kuehnstraße 61 22045 Hamburg Germany

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2 Terminology Active working element WA22366A 1) Handle 2) Telescope release button 3) HF connector (for HF cable’s right angle plug) 4) Telescope channel 5) Thumb ring 6) HF connector (for HF cable’s straight plug) 7) Electrode release button 8) Locking cone 9) Electrode guiding tube

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13 Passive working element WA22367A 1) Handle 2) Telescope release button 3) HF connector (for HF cable’s right angle plug) 4) Telescope channel 5) Thumb ring 6) HF connector (for HF cable’s straight plug) 7) Electrode release button 8) Locking cone 9) Electrode guiding tube

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14 HF cable WA00013A 1) Straight plug 2) Right angle plug

HF-resection electrode WA22301D, WA22302D, WA22305D, WA22306D, WA22331D, WA22332D, WA22351A, WA22351C, WA22355A, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538A, WA22538C, WA22539D, WA22557C, WA22558C 1) Cutting loop 2) Stabilizing tube

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15 HF-resection electrode with instrument recognition WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C, WA22657C 1) HF-resection electrode 2) Generator plug 3) Straight plug 4) Right angle plug 5) HF cable

2.1 Shape of HF-Resection Electrodes WA22301D, WA22302D, WA22305D, WA22306D, WA22503D, WA22507D, WA22537D, WA22602D, WA22603D, WA22606D, WA22607D Loop.

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16 WA22558C Loop with runner.

WA22351A, WA22351C, WA22538A, WA22538C, WA22651C Roller.

WA22355A, WA22355C, WA22655C Needle.

WA22521C, WA22523C, WA22621C, WA22623C Band.

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17 WA22557C, WA22657C Button.

WA22331D, WA22332D, WA22539D, WA22632D Angled loop.

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2.2 Color Codes of HF-Resection Electrodes 1) Size. Inner sheath [Fr.] Outer sheath [Fr.] Yellow

24

26/27

Grey

24/26/28

26/27/28

2) Blue for resection with saline solution.

3) Direction of view. Red 30° Blue 12° White 12°/30°

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3 Compatible Components WARNING! Risk of injury to the patient and/or user Use only compatible equipment as listed in this section. If other combinations are used, the full responsibility is assumed by the user. Future products may also be compatible. For further details contact an Olympus representative. NOTE! Product may not be available in all sales territories.

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20 Urology

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22 Urology

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